Life Of A Catheter

After clinical use, the devices are packaged per NEScientific Handling Instructions, which helps decrease potential damage to the devices and increase the reprocessing potential. Using the pre-paid FedEx® labels provided, Customer’s schedule FedEx pickup and the devices are on the way to NEScientific.

Once the devices arrive at NEScientific, the devices are initially inspected for potential issues or unrepairable damage that would prevent them from being reprocessed. While NEScientific is constantly improving their reprocessing capabilities, there are strict quality control guidelines as to what is acceptable to be reprocessed.

Every device goes through the specific FDA 510(k) cleared decontamination and cleaning process for that type of device. Each device is also manually inspected throughout this step-in production and during every other step in the production process.

NEScientific proprietary technology is coupled with FDA510(k) cleared cleaning methods to prepare the device safely and effectively for another clinical use. Further manual inspection, one device at a time occurs to confirm the device has had each step in the process completed.

Devices are individually tested for functionality and inspected for quality to make sure there is no compromise in performance. After functional testing, each device is pouched and labeled in accordance with FDA regulations for medical devices.

After making it through the reprocessing process, devices are sterilized using 100% ETO. Post-sterilization testing confirms the devices are non-pyrogenic and ready for a final by hand individual device inspection.

Devices are cleared by the NEScientific Quality & Regulatory team as having met all specifications of the FDA and ISO:13485 to be available for commercial sale. The devices are added to inventory and able to be purchased by Customers.